Advanced Regenerative Medicine

Osteoarthritis

Among the various forms of degenerative joint disease, osteoarthritis (OA) is by far the most common and represents a painful chronic condition that can affect any synovial joint.

Osteoarthritis and Demographics

Among the various forms of degenerative joint disease, osteoarthritis (OA) is by far the most common and represents a painful chronic condition that can affect any synovial joint.

Disease prevalence is increasing in parallel with an aging population and will impose significant socioeconomic burden over the coming decades.

Arthritis is the most common source of disability among adults in the United States; in 2003, the disease afflicted 50 million Americans, and this number is expected to increase to 67 million by 2030.

The cost attributable to arthritis in the United States in 2003 was $128 billion, a figure that will certainly increase in conjunction with health care cost inflation and the number of patients projected to be afflicted with degenerative joint disease.

Complicating this reality are the limited treatment options for OA. No pharmaceutical or non-operative therapies have demonstrated unequivocal efficacy in reversing or halting disease progression, restricting therapy to long-term management of exacerbating factors and pain control.

Mesenchymal stem cells

Mesenchymal stem cells (MSCs) have been proposed as an optimal regenerative cellular therapeutic for degenerative musculoskeletal conditions like OA. These cells are found in a variety of tissues and have the ability to rapidly proliferate and differentiate to musculoskeletal lineages including bone and cartilage. A significant body of research has also demonstrated that these cells orchestrate important immunologic functions through modulation of the local inflammatory response. Taken together, these factors support the theoretical ability of MSCs to deter degenerative joint disease.

Safety

Adipose tissue-derived mesenchymal stem cells (Ad MScs) represent an attractive and ethical cell source for stem cell therapy.

With the recent demonstration of MSC homing properties, intravenous applications of MSCs to cell-damaged diseases have increased. The toxicity and tumourigenicity of human Ad MScs were investigated for clinical application. Culture-expanded hAdMSCs showed the typical appearance, immunophenotype, and differentiation capacity of MSCs, and were genetically stable at least 12 passages in culture.

Cells suspended in physiological saline maintained their MSC properties in a cold storage condition for at least 3 days. To test the toxicity of hAdMSCs, different doses of hAdMSCs were injected intravenously into immunodeficient mice, and the mice were observed for 13 weeks. Even at the highest cell dose (2.5×10(8) cells/kg body weight), the SCID mice were viable and had no side effects.

A tumourigenicity test was performed in Balb/c-nu nude mice for 26 weeks. Even at the highest cell dose (2×10(8) MSCs/kg), no evidence of tumour development was found. In a human clinical trial, 8 male patients who had suffered a spinal cord injury >12 months previous were intravenously administered autologous hAdMSCs (4×10(8) cells) one time. None of the patients developed any serious adverse events related to hAdMSC transplantation during the 3-month follow-up. In conclusion, the systemic transplantation of hAdMSCs appears to be safe and does not induce tumour development.

Patented Production Method

Previous studies suggest that a hypoxic condition promotes self-renewal of undifferentiated mesenchymal stem cells and enhances their therapeutic potential. Our ExoRAP and ExoPAN technology uses a protocol of pre-treatment of the cultured MSC in special media and various anoxia conditions instead of hypoxia. With this protocol a 30 fold increase in RNA content per cell can be achieved. The technology is successfully being used in regenerative treatments in human ExoRAP and ExoPAN technology and animal patients.

Summary of therapeutic success

Prevention of cartilage destruction: we tested several versions of secretome on cartilage tissue explants. The explants were treated with monoiodoacetate which leads to massive osteoarthritis. Concomitant therapy with secretome prevented cartilage degeneration.
Regeneration of cartilage defects: cartilage lesions were regenerated with secretome
Secretome and/or stem cells are the only known treatment which regenerates cartilage
Secretome and stem cells also had an anti-inflammatory effect
Intravenous injections in humans with hip osteoarthritis had a big improvement and avoided hip replacement and intraarticular injections
Intraarticular injections of secretome (no! cells) lead to regeneration of cartilage and rebuilding of meniscus and cruciate ligaments.
We have developed and researched a panel of biomarkers (blood or urine) to prove regeneration, anti-degeneration and anti-inflammation in osteoarthritis, so that monitoring can be done (a part from MRI) with blood analysis.

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